1. Field of the Invention
The present invention relates, in general, to a circulation set for a temperature-controlled catheter and, in particular, to a circulation set for a hypothermia catheter.
2. Background Information
Numerous catheters exist for non-invasive treatment of a variety of internal areas and regions of a patient. Many of these catheters circulate a fluid through a distal portion of the catheter. An example of a type of catheter that may circulate fluid through a distal portion of the catheter is a hypothermia catheter. A hypothermia catheter is inserted into the bloodstream of a patient in order to induce partial or total body hypothermia. A hypothermia catheter may be used to reduce the effects of certain bodily injuries to the brain as well as other organs. A hypothermia catheter may include a heat transfer element located at a distal portion of the catheter. A heat transfer fluid may be circulated along an internal portion of the heat transfer element, drawing heat from the heat transfer element. This, in turn, causes heat to be removed from blood flowing along an external surface of the heat transfer element, causing the resulting blood to be cooled. The collective components that supply fluid to the catheter and regulate the temperature of the fluid being delivered to and/or returning from the distal portion are referred to herein as the circulation set and may include one or more of the following: a fluid reservoir, a pump, a filter, a heat exchanger, a temperature sensor, a pressure sensor, and tubing.
The inventors of the present invention have recognized that as health insurance companies constantly cut back on the amount they are willing to pay for medical devices used in medical procedures, it important to produce a quality circulation set made of inexpensive components. Drawbacks of circulation sets in the past are that many or all of the components of the set are made of relatively expensive non-disposable components intended to be used numerous times before being disposed of, any disposable components of the circulation set are not conveniently separable from the non-disposable components, and the disposable components that are used are not made of readily-available cheap components. The inventors of the present invention have also recognized that it would be better for insurance reimbursement purposes if the circulation set was made of relatively inexpensive components and was essentially disposable.
A first aspect of the invention involves a single-use, disposable circulation set for a heat transfer catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable pump adapted to pump heat transfer fluid through the catheter from the fluid reservoir, a single-use, disposable filter assembly adapted to remove impurities from the heat transfer fluid, a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir, pump, filter assembly, heat exchanger, and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A second aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir, heat exchanger, and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A third aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A fourth aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable supply line communicating the fluid reservoir and heat exchanger, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating with the fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A fifth aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the heat exchanger and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating with the temperature and pressure sensor block member, and adapted to be connected to the catheter for returning heat transfer fluid from the catheter.
A sixth aspect of the invention involves a method of using a circulation set for a heat transfer catheter. The method includes attaching a single-use, disposable circulation set including a fluid reservoir, a pump, a heat exchanger member, a condition sensor member, supply line, and return line to the catheter, circulating heat transfer fluid and controlling the temperature of the same through the catheter with the circulation set, and disposing the circulation set after a single use.
A seventh aspect of the invention involves a method of using a circulation set for a heat transfer catheter. The method includes providing a single-use, disposable circulation set for the catheter, the circulation set comprising a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable pump adapted to pump heat transfer fluid through the catheter from the fluid reservoir, a single-use, disposable filter assembly adapted to remove impurities from the heat transfer fluid, a single-use, disposable heat exchanger member adapted for use with a multi-use, non-disposable heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir, pump, filter assembly, heat exchanger, and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir; connecting the return line and supply line to the catheter; coupling the single-use, disposable temperature and pressure sensor block member with the multi-use, non-disposable temperature and pressure sensor electronics member; coupling the single-use, disposable heat exchanger member with the multi-use, non-disposable heat exchanger; circulating heat transfer fluid and controlling the flow rate and temperature of the same through the catheter with the pump, heat exchanger, and the temperature and pressure sensor block member and electronics member; and disposing the circulation set after a single use.
An eighth aspect of the invention involves a disposable fluid reservoir for supplying a heat transfer fluid to a circulation set of a heat transfer catheter, the circulation set including a supply line for supplying heat transfer fluid to the heat transfer catheter for fluid circulation purposes and a return line for returning heat transfer fluid to the fluid reservoir for fluid circulation purposes. The fluid reservoir includes an intravenous (xe2x80x9cIVxe2x80x9d) bag normally used for the intravenous delivery of one or more fluids to the vasculature of a patient, the bag including a top and a bottom, an inlet line located within the bag and adapted to communicate with the return line for returning fluid to the bag during circulation, and an outlet line located within the bag and adapted to communicate with the supply line for supplying fluid to the catheter during circulation.
A ninth aspect of the invention involves a fluid reservoir for supplying a heat transfer fluid to a circulation set of a heat transfer catheter, the circulation set including a supply line for supplying heat transfer fluid to the heat transfer catheter for fluid circulation purposes and a return line for returning heat transfer fluid to the fluid reservoir for fluid circulation purposes. The fluid reservoir includes a fluid reservoir body including a top and a bottom, an air-removal mechanism located in the body near the top of the body, an inlet line including an outlet located within the body, the inlet line adapted to communicate with the return line for returning fluid to the body during circulation, an outlet line including an inlet located at least partially within the body, the outlet line adapted to communicate with the supply line for supplying fluid to the catheter during circulation, and wherein the outlet of the inlet line is located closer to the air-removal mechanism than the inlet of the outlet line.
A tenth aspect of the invention involves a method of using a fluid reservoir in a circulation set for a heat transfer catheter, the circulation set including a supply line for supplying heat transfer fluid to the catheter for fluid circulation purposes and a return line for returning heat transfer fluid to the fluid reservoir for fluid circulation purposes. The method includes using intravenous (xe2x80x9cIVxe2x80x9d) bag normally used for the intravenous delivery of one or more fluids to the vasculature of a patient as a fluid reservoir in a circulation set for a heat transfer catheter, an inlet line located within the IV bag and adapted to communicate with the return line for returning fluid to the IV bag during circulation, and an outlet line located within the IV bag and adapted to communicate with the supply line for supplying fluid to the catheter during circulation; circulating heat transfer fluid from the catheter through the return line, into the inlet line, through the IV bag, out the outlet line, and through the supply line to the catheter; and disposing the IV bag after a single use.
An eleventh aspect of the invention involves a method of using a fluid reservoir in a circulation set for a heat transfer catheter, the circulation set including a supply line for supplying heat transfer fluid to the catheter for fluid circulation purposes and a return line for returning heat transfer fluid to the fluid reservoir for fluid circulation purposes. The method includes providing a fluid reservoir, the fluid reservoir including a fluid reservoir body, an air-removal mechanism located in the body, an inlet line including an outlet located within the body, the inlet line adapted to communicate with the return line for returning fluid to the body during circulation, an outlet line including an inlet located at least partially within the body, the outlet line adapted to communicate with the supply line for supplying fluid to the catheter during circulation, and wherein the outlet of the inlet line is located closer to the air-removal mechanism than the inlet of the outlet line; circulating heat transfer fluid from the catheter through the return line, into the inlet line, through the fluid reservoir body, out the outlet line, and through the supply line to the catheter; and removing air from the circulation set with the air-removal mechanism.
A twelfth aspect of the invention involves a temperature and pressure sensor assembly of a circulation set of a heat transfer catheter for measuring temperature and pressure of a heat transfer fluid flowing through a supply line for supplying heat transfer fluid to a catheter for fluid circulation purposes and a return line for returning heat transfer fluid from the catheter for fluid circulation purposes. The temperature and pressure sensor assembly includes a multi-use, non-disposable temperature and pressure sensor electronics member, and a single-use, disposable temperature and pressure sensor block member removably coupled to the electronics member so that the block member may be discarded after a single use and the electronics member may be used multiple times with different disposable block assemblies, the block member adapted to communicate with the supply line and return line.
A thirteenth aspect of the invention involves a single-use, disposable temperature and pressure sensor block member of a temperature and pressure sensor assembly of a circulation set of a heat transfer catheter for measuring temperature and pressure of a heat transfer fluid flowing through a supply line for supplying heat transfer fluid to a catheter for fluid circulation purposes and a return line for returning heat transfer fluid from the catheter for fluid circulation purposes. The temperature and pressure sensor block member includes a single-use, disposable temperature and pressure sensor block member adapted to be removably coupled to a multi-use, non-disposable temperature and pressure sensor electronics member so that the block member may be discarded after a single use and the electronics member may be used multiple times with different disposable block assemblies. The block member includes a pressure sensor hole adapted to communicate with a supply lumen and receive a pressure sensor of the electronics member, a temperature sensor hole adapted to communicate with the supply lumen and receive a temperature sensor of the electronics member, a pressure sensor hole adapted to communicate with a return lumen and receive a pressure sensor of the electronics member, and a temperature sensor hole adapted to communicate with the return lumen and receive a temperature sensor of the electronics member.
A fourteenth aspect of the invention involves a method of using a single-use, disposable temperature and pressure sensor block member of a temperature and pressure sensor assembly of a circulation set for a heat transfer catheter. The method includes removably attaching a single-use, disposable temperature and pressure sensor block member of a temperature and pressure sensor assembly to a multi-use, non-disposable temperature and pressure sensor electronics member; coupling the single-use, disposable temperature and pressure sensor block member to the heat transfer catheter; circulating heat transfer fluid through the block member and heat transfer catheter; sensing temperature and pressure of heat transfer fluid flowing through the block member; and disposing the block member but not the electronics member after a single use of the heat transfer catheter.
A fifteenth aspect of the invention involves a method of using a single-use, disposable temperature and pressure sensor block member of a temperature and pressure sensor assembly of a circulation set for a heat transfer catheter. The method includes removably attaching a single-use, disposable temperature and pressure sensor block member of a temperature and pressure sensor assembly to a multi-use, non-disposable temperature and pressure sensor electronics member. The block member includes a supply lumen adapted to be coupled to the heat transfer catheter for delivery of heat transfer fluid thereto, a return lumen adapted to be coupled to the heat transfer catheter for delivery of heat transfer fluid therefrom, a pressure sensor hole adapted to communicate with the supply lumen and receive a sensor of the electronics member, a temperature sensor hole adapted to communicate with the supply lumen and receive a temperature sensor of the electronics member, a pressure sensor hole adapted to communicate with the return lumen and receive a pressure sensor of the electronics member, and a temperature sensor hole adapted to communicate with the return lumen and receive a temperature sensor of the electronics member; coupling the supply lumen and return lumen of the block member with the heat transfer catheter; circulating heat transfer fluid through the supply lumen of the block member, heat transfer catheter, and return lumen of the block member; sensing temperature and pressure of heat transfer fluid flowing through the supply lumen of the block member with the temperature and pressure sensors of the electronics member and sensing temperature and pressure of heat transfer fluid flowing through the return lumen of the block member with the temperature and pressure sensors of the electronics member; and disposing the block member but not the electronics member after a single use of the heat transfer catheter.
A sixteenth aspect of the invention involves a method of using a heat exchanger member in a circulation set for a heat transfer catheter, the circulation set including a heat exchanger adapted to transfer heat between the heat exchanger and heat transfer fluid within the heat exchanger member for temperature control of the heat transfer fluid. The method includes providing a single-use, disposable heat exchanger member with the heat exchanger, the heat exchanger member including at least one passage adapted to allow heat transfer fluid to flow therethrough; transferring heat between the heat exchanger and the heat transfer fluid in the heat exchanger member, either to the heat transfer fluid from the heat exchanger or from the heat transfer fluid to the heat exchanger; and disposing the heat exchanger member, but not the heat exchanger after a single use of the heat transfer catheter.
A seventeenth aspect of the invention involves a method of using a heat exchanger member in a circulation set for a heat transfer catheter, the circulation set including a heat exchanger adapted to transfer heat between the heat exchanger and heat transfer fluid within the heat exchanger member for temperature control of the heat transfer fluid. The method includes providing a single-use, disposable IV or intravenous bag normally used for the intravenous delivery of one or more fluids to the vasculature of a patient as a heat exchanger member with the heat exchanger, the IV bag including at least one passage adapted to allow heat transfer fluid to flow therethrough; transferring heat between the heat exchanger and the heat transfer fluid in the IV bag, either to the heat transfer fluid from the heat exchanger or from the heat transfer fluid to the heat exchanger; and disposing the IV bag but not the heat exchanger after a single use of the heat transfer catheter.
An eighteenth aspect of the invention involves a heat exchanger of a circulation set for a heat transfer catheter. The heat exchanger includes a pair of heat exchanger mold members each including an insulative body with an inner surface, a heat conductive face bonded to the inner surface of the face, and one or more heat transfer liquid paths located between the inner surface of the insulative body and the heat conductive face. The heat conductive face includes a mold configuration and is adapted, when placed together with the opposite face, to receive a disposable heat exchanger member and shape the disposable heat exchanger member into one or more heat transfer paths for transferring a heat transfer fluid therethrough.
A nineteenth aspect of the invention involves a method of identifying a heat transfer catheter or heat transfer element of a heat transfer catheter. The method includes measuring catheter pressure at a variety of heat transfer fluid flow rates; determining a slope of a best fit line through a variety of data points determined by the measuring step; and identifying the heat transfer catheter or heat transfer element by comparing the slope determined by the determining step to established slopes for a variety of different heat transfer catheters or heat transfer elements. In an implementation of the invention, the method further includes controlling one or more operational parameters of the catheter or heat transfer element based on the heat transfer catheter or heat transfer element identified.
The novel features of this invention, as well as the invention itself, will be best understood from the attached drawings, taken along with the following description, in which similar reference characters refer to similar parts, and in which: